(84 days)
Not Found
Not Found
No
The description focuses on digital image processing (flicker removal, enhancement) and recording/display, with no mention of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML algorithms.
No
The device is used for image recording, display, and enhancement for diagnostic purposes, not for treating a condition.
Yes
The description explicitly states, "The images on the screen can be enhanced to allow for easier, better diagnosis," indicating its role in aiding the diagnostic process.
No
The description explicitly states the system "interfaces with new or existing systems" and is "integrated with the room's x-ray equipment," implying the inclusion of hardware components beyond just software. It also mentions acquiring images from a "video camera," which is a hardware component.
Based on the provided information, the OptiView device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- OptiView's Function: OptiView is described as a digital image recording and display system that interfaces with X-ray equipment and video cameras to acquire, process, and display images of the cardiac anatomy during procedures. It works with images generated within the body using external imaging modalities (X-ray).
- No Specimen Analysis: There is no mention of OptiView analyzing any biological specimens taken from the patient.
Therefore, OptiView falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
OptiView is a digital image recording and display system for use in a cardiac cath lab or optivion is a digital many suite. It is a digital upgrade for the cardiac catheterization lab. It interfaces with new or existing systems to provide high quality diagnostic images and an instant increase in productivity. Integrated with the room's x-ray equipment OptiView acquires the flickered images from the video camera, gets rid of the flicker, and provides flicker-free live images displayed on a monitor in the cath lab and in the control room. The OptiView system records patient demographics and the images from the cardiac catheterization procedure (as well as radiography/fluoroscopy suite). The images on the screen can be enhanced to allow for easier, better diagnosis, and the images and the information can be reviewed during the case as well as after the case is completed.
Product codes
90 LLZ, 90 LMB
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
x-ray, video camera
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
cardiac cath lab, control room
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the eagle in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 9 1997
Moshe Zchut Vice President, Technology OptiMed Technologies, Inc. 293 Eisenhower Parkway Livingston, NJ 07039
Re: K972520
OptiView/Medical Image Record and Display System Dated: July 1, 1997 Received: July 7, 1997 Regulatory class: Unclassified Procode: 90 LLZ / 90 LMB
Dear Mr. Zchut:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Wisbranding by reference to premarket notification" (2) CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
h. Tiau Yu.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Ofti Vicw
Indications For Use:
OptiView is a digital image recording and display system for use in a cardiac cath lab or optivion is a digital many suite. It is a digital upgrade for the cardiac catheterization lab. It interfaces with new or existing systems to provide high quality diagnostic images and an instant increase in productivity.
Integrated with the room's x-ray equipment OptiView acquires the flickered images from the video camera, gets rid of the flicker, and provides flicker-free live images displayed on a monitor in the cath lab and in the control room.
The OptiView system records patient demographics and the images from the cardiac catheterization procedure (as well as radiography/fluoroscopy suite). The images on the screen can be enhanced to allow for easier, better diagnosis, and the images and the information can be reviewed during the case as well as after the case is completed.
\PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ushrid A. kymm
Division of Reproductive, Abdominal, ENT and Radiological Dev 510(k) Number
Frescription Use_X (Per 21 CFR 801.109)
ಲ್ಲಾ
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)